Treatment of Refractory Angina Pectoris by Shock Wave Therapy
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|ClinicalTrials.gov Identifier: NCT00776568|
Recruitment Status : Unknown
Verified October 2008 by Universal Research Group.
Recruitment status was: Active, not recruiting
First Posted : October 21, 2008
Last Update Posted : October 21, 2008
|Condition or disease||Intervention/treatment||Phase|
|Angina Pectoris||Procedure: Extra-corporeal shockwave Drug: Anti-hypertensive drugs||Phase 3|
Patients with advanced CAD frequently have limited symptoms with recurrent angina, angina at low work thresholds, breathlessness, and other debilitating conditions. These patients have often been through several "re-do" coronary bypass procedures and multiple percutaneous coronary interventions.
Surgical and interventional options for these patients typically have been exhausted or will result in only partial revascularization. Therefore, therapy remains limited to the use of multiple anti-anginal medications, reduced activity, exertion, and stress level, and significant alteration and limitation of lifestyle.
The goal of this emerging approach is to therapeutically induce the growth and development of new vasculature in zones of severe ischemia in the myocardium, with the hope that new capillaries and arterioles generated will connect to remnant existing vasculature. These neovessels are viewed to act as collaterals, perfusing ischemic territories unapproachable by macro procedures such as PCI and/or CABG.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Refractory Angina Pectoris|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||August 2009|
|Active Comparator: 2||
Drug: Anti-hypertensive drugs
ACE inhibitors, Ca channel blockers, Beta blockers, Diuretics, Cholesterol lowering agents and/or other drugs used alone or in combination, as prescribed.
Procedure: Extra-corporeal shockwave
Low intensity shock waves are applied as 300 shocks per visit for 09 visits. The treatment visit is carried at week 1, 5 and 9.
- Alleviation of anginal symptoms [ Time Frame: 06 months ]
- The change in SPECT in perfusion from baseline to 6 months post-baseline (17 segments model [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776568
|Karachi Institute of Heart Diseases|
|Principal Investigator:||Prof. Abdul Samad, MD||Karachi Institute of Heart Diseases|